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510(k) Data Aggregation
(208 days)
When used as a cervical intervertebral body fusion device, the Chesapeake implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. Cervical IBF implants are intended for use at one level in the cervical spine, from C2 to T1, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is intended to be used in patients who have had six weeks of non-operative treatment.
When used as a lumbar intervertebral body fusion device, the Chesapeake implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. Lumbar I implants are intended for use at either one level or two contiguous levels in the lumbar spine. from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The lumbar device is intended to be used in patients who have had six months of non-operative treatment.
The Chesapeake Spinal System may be used as a stand-alone device or in conjunction with supplemental fixation. When used as a stand-alone device the Chesapeake spacers are intended to be used with the bone screws provided. When using a 2 screw implant, 2 screws must be used. When using a 3 screw implant 3 screws must be used.
The Chesapeake Spinal System consists of PEEK and titanium spacers and titanium bone screws for intervertebral body fusion, without the need for supplementary fixation. The spacers are hollow tube structures that can be packed with bone graft and allow for passage of screws for fixation to the vertebral body. Multiple sizes of implants are available to accommodate anatomical variations.
Materials: The spacers are manufactured from Medical Grade PEEK (Polyetheretherketone) OPTIMA® LT1 (Invibio™) per ISO 10993-1 USP Class VI, and ASTM F2026 and CP titanium per ASTM F67. Tantalum beads /rods to be Grade UNS R05200, UNS R05400 according to ASTM F560. The screws are fabricated from Ti6Al4V per ASTM 1472.
Function: The Chesapeake intervertebral body fusion devices are designed to provide support and stabilization of the cervical and lumbar segments of the spine.
The purpose of this 510(k) submission is to add offset cervical implants to the system.
The provided text is a 510(k) summary for a medical device (Chesapeake Spinal Stabilization System) seeking substantial equivalence to predicate devices. It focuses on the device's design, materials, intended use, and comparison to existing products based on mechanical testing. It does not contain information about acceptance criteria for device performance in terms of diagnostic accuracy, nor does it describe a study involving human readers or AI in a diagnostic context.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance related to diagnostic accuracy.
- Sample sizes for test sets, data provenance, number of experts, adjudication methods for ground truth, MRMC studies, or standalone algorithm performance in a diagnostic context.
- Ground truth type for diagnostic purposes.
- Sample size for training sets in a diagnostic context.
- How ground truth for a training set was established in a diagnostic context.
The document focuses on the mechanical and biological safety and efficacy of an implantable device, not a diagnostic AI.
However, I can extract the following information about the device's performance based on the type of study presented (mechanical testing):
1. Table of Acceptance Criteria and Reported Device Performance (Mechanical Testing):
| Acceptance Criteria Category (Implied) | Device Performance |
|---|---|
| Static Compression Strength | Determined to be substantially equivalent to predicate devices (Implied that performance met or exceeded predicate device performance). |
| Dynamic Compression Durability | Determined to be substantially equivalent to predicate devices (Implied that performance met or exceeded predicate device performance). |
| Static Torsion Resistance | Determined to be substantially equivalent to predicate devices (Implied that performance met or exceeded predicate device performance). |
| Dynamic Torsion Durability | Determined to be substantially equivalent to predicate devices (Implied that performance met or exceeded predicate device performance). |
| Subsidence Resistance | Determined to be substantially equivalent to predicate devices (Implied that performance met or exceeded predicate device performance). |
| Expulsion Resistance | Determined to be substantially equivalent to predicate devices (Implied that performance met or exceeded predicate device performance). |
2. The Study that Proves the Device Meets Acceptance Criteria:
The study referenced is a mechanical testing study performed in accordance with ASTM 2077.
Details on the study:
- Sample size used for the test set: Not explicitly stated for each test, but standard mechanical testing involves a sufficient number of samples to demonstrate statistical significance or conformity to standards.
- Data provenance: Not applicable in the context of diagnostic data. The "data" here are mechanical test results from the manufactured device.
- Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable. Ground truth for mechanical testing is defined by the ASTM standards and the physical properties measured.
- Adjudication method for the test set: Not applicable. Performance is measured against physical standards specified in ASTM 2077.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: No, not applicable. This is a mechanical device, not a diagnostic AI.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No, not applicable. This is a physical device, not an algorithm.
- The type of ground truth used: Standardized mechanical properties and performance established by ASTM 2077 specifications and comparison to the mechanical performance of established predicate devices.
- The sample size for the training set: Not applicable. There is no "training set" in the context of mechanical device testing as described here.
- How the ground truth for the training set was established: Not applicable.
Summary of what is presented in the 510(k) summary:
The Chesapeake Spinal Stabilization System underwent mechanical testing (static compression, dynamic compression, static torsion, dynamic torsion, subsidence, and expulsion) as per ASTM 2077. The reported performance is that the device was "determined to be substantially equivalent to predicate devices." This statement implies that the device's mechanical properties and performance met or exceeded the established safety and effectiveness benchmarks set by the predicate devices and the relevant ASTM standard. The purpose was to demonstrate substantial equivalence for regulatory approval, not to assess diagnostic performance.
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